It is necessary during the course of treatment of certain diseases and during certain procedures to provide tracheotomies on the individuals afflicted with such diseases, or on whom such procedures are to be performed or are being performed. In many cases, the tracheotomies remain patent for extended time periods, making it necessary and/or desirable to provide devices which permit such tracheotomized individuals to speak. While some individuals are able and willing to occlude the outer ends of their tracheotomy tubes with a finger tip when they want to speak, many individuals are not.
Some devices which perform the occlusion function are known. There is, for example, the Tucker speaking valve for use with the Jackson tracheostomy tube. Additionally, there are a number of one-way valves available from various sources that fit onto the outer ends of standard size tracheostomy tubes. These one-way valves close when pressure in the individual's trachea rises to so-called “speaking” pressure, redirecting air from the tracheostomy tube upward through the larynx, permitting phonation. Such one-way valves include, for example: the valve described in U.S. Pat. No. 6,588,428; the Montgomery( tracheostomy speaking valve (product code 221201) and TRACOE® PhonAssist speaking valve (product code 650-T), both available from Boston Medical Products; the Hood speaking valve (code SPV-3015) and Medin low resistance speaking valve (code SPV-2055), both available from Hood Laboratories, 575 Washington Street, Pembroke, Mass. 02359; the Shiley Phonate® speaking valve (product designation SSVO) available from Nellcor Puritan-Bennett LLC; and, the Passy-Muir tracheostomy & ventilator swallowing and speaking valve (PMV 005) available from Passy-Muir Inc. These valves are generally of a similar size and configuration designed to slide onto the standard 15 mm external (ventilator) end of a tracheostoma tube or cannula. The teachings of these references are hereby incorporated herein by reference. This listing is not intended to be a representation that a complete search of all relevant art has been made, or that no more pertinent art than that listed exists, or that the listed art is material to patentability. Nor should any such representation be inferred.
Problems arise with a valve such as the Tucker speaking valve in which the flapper of the valve is positioned midway along the length of the Tucker speaking valve's inner cannula. First, the flapper is oriented such that it lies at an angle across the inner cannula. This orientation provides areas in which secretions can become lodged, interfering with the normal function of the valve's flapper and adversely affecting the wearer's ability to speak while wearing it. Further, because the Tucker speaking valve, like the Jackson tracheostomy tube, is made of metal (specifically a silver alloy), the valve is heavy and expensive. Additionally, the valve leaks whether it is in the closed (non-speaking) or open (speaking) orientation.
The major problem with one-way valves that are designed to fit onto the outer ends of standard size tracheostomy tubes is that they project out quite far from the neck of the wearer when they are installed on the outer end of the tube. The bodies of most of these are in the range of 0.75 inch (about 19 mm) long and are designed to slide over the outer end of an inner cannula, which outer end itself projects about 0.75 inch (about 19 mm) beyond the outer (ventilator) end of an outer cannula or tracheostomy tube. This results in an assembly that extends forward not uncommonly 1-1.75 inch (about 2.5-4.4 cm) or so. Not surprisingly, the tracheostomy tube wearer would prefer not to have an additional 1-1.75 inch (about 2.5-4.4 cm) or so apparatus projecting out from his or her neck in order to be able to speak without having to occlude the outer end of his or her tracheostomy tube each time he or she wanted to say something.